EUCTR2019-003591-40-AT进行中（未招募）1 期
Efficacy of Cannabidiol in Treatment of Pain due to symptomatic Osteoarthritis of the Knee: A randomized, double-blind, placebo-controlled - Efficacy of Cannabidiol in Knee Osteoarthritis
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie0 个研究点目标入组 86 人开始时间: 2020年3月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient must be willing and able to give informed consent for
- •participation in the study
- •Age 18-80 years
- •Knee Pain
- •WOMAC Pain Subscale = 5 during screening
- •Mean Visual Analogue Scale (VAS) = 5 during 1 week of screening.
- •Fulfilment of the clinical criteria of the American College of
- •Rheumatology for knee OA 8
- •X-ray or MRI confirmation of knee osteoarthritis within the previous
- •All medications or interventions for pain due to knee osteoarthritis
- •must have been stable for two weeks prior to screening and patient is
- •willing to maintain a
- •stable regimen throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Current mood disorder (dysthymia, bipolar mood disorder)
- •Major Depression > 12 months (Beck Depression Inventory Score =
- •History of a psychoactive substance use disorder within the preceding
- •Major coexisting medical illness (e.g. severe heart failure, pulmonary
- •hypertension, renal insufficiency)
- •Acute myocardial infarction
- •Uncontrolled hypertension
- •History of convulsion
- •Pregnancy; women of childbearing age will be required to use
- •contraceptives during the duration of the study. Furthermore a
- •pregnancy test will be performed prior to the beginning of the study and
- •once a month during the study period.
- •Breast feeding
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Allergy to study medication
- •Recent intra-articular corticosteroid or hyaluronic acid injection in the
- •knee joint. Patients must be willing to abstain from such interventions
- •during the entire study
- •Use of the following medication:
- •- opioids except for tramadol,
- •- benzodiazepines other than indicated at low doses for sleep disorders
- •Impaired kidney function (Creatinine > 1.5mg/dl)
- •Patient has significantly impaired hepatic function
- •defined as any of the following:
- •- Alanine aminotransferase (ALT) or aspartate aminotransferase
- •(AST) >5 × upper limit of normal (ULN).
- •- ALT or AST >3 × ULN and (total bilirubin [TBL] >2 × ULN
- •or international normalized ratio [INR] >1.5).
- •- ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
- •right upper quadrant pain or tenderness, fever, rash,and/or eosinophilia
- •Patient is currently using or has in the past used recreational or
- •medicinal cannabis or synthetic cannabinoid based medications within 3
- •months prior to study entry
- •Patient is unwilling to abstain from using recreational or medicinal
- •cannabis, or synthetic cannabinoid based medications during the study
- •Patients who are not able to understand the study measures and are
- •not able to complete pain assessment forms.
研究者
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